Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00286-1
Product Name/Description	Bard ConQuest PTA Balloon Dilatation Catheter (Intended for use in Percutaneous Transluminal Angioplasty of the femoral, renal and iliac arteries) Product Codes: CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124 Lot Numbers:REYA0973, REYA2566, REYC0372, REYC0950, REYC1426, REYC2200, REYC2365, REYC2825, REYC2575 ARTG Number: 137802
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	27/03/2015
Responsible Entity	Bard Australia Pty Ltd
Reason/Issue	Bard Peripheral Vascular (BPV) has identified that the product code / lot number combinations affected may be at risk of having deflation related issues. In the event a PTA balloon will not deflate, immediate intervention is required in order to deflate the balloon and allow for continued blood flow. In many cases, this can be accomplished percutaneously by inserting a device (i.e., guidewire or sheath) to the PTA balloon and puncturing the balloon and/or a sheath, allowing its withdrawal. This can usually be completed through the same vascular access, however, may require additional access. In the event a PTA balloon cannot be deflated while in the extremities (i.e., superficial femoral artery or AV fistula), it may be possible to insert a sterile needle through the skin and reach the balloon and pierce it in order to deflate it. In the event a percutaneous approach cannot successfully deflate the PTA balloon, an open surgical approach will be required.
Recall Action	Recall
Recall Action Instructions	Customers are advised to remove any affected product from their shelves and contact Bard Australia Customer Service to arrange for any affected product to be returned and replaced. This action has been closed-out on 1/06/2016.
Contact Information	1800 257 232 - Bard Australia